ABTECT-1 Study

This study is being done to learn more about an investigational medication and its effect in people with ulcerative colitis. The study aims to see if 2 different doses of the investigational medication work in controlling symptoms and how safe the investigational medication is.

You may be able to take part in this study if you:

  • Are 18 years of age or over

  • Have been diagnosed with ulcerative colitis

  • Have experienced inadequate, no response, or loss of response while on other or previous ulcerative colitis medication

What is the ABTECT-1 Study?

The ABTECT-1 Study is made up of 3 parts.

Part 1

Screening (up to 4 weeks)

You will visit the study center at least once in this period to see if the study is right for you and whether you want to take part. You will also have a colonoscopy or endoscopy, and eye exams during the screening period. The colonoscopy/endoscopy and eye exams may require separate visits.

Part 2

Study Treatment (about 8 weeks)

You will visit the study center 3 times during the study treatment period for study assessments. You will take the study medication once every day. At the third visit, you will be given the option to take part in a 44-week maintenance study. If you agree to take part in the maintenance study, you will continue taking the study medication.

Part 3

Follow-up (about 4 weeks)

If you do not take part in the maintenance study, you will visit the study center one last time for study assessments after you have finished taking the study medication.

ABTECT-1 Study Q & A

What will this study involve?

If you participate in the ABTECT-1 Study you will be in the study for up to 16 weeks.

You will be randomly assigned to 1 of 3 study groups. Depending on the group you are assigned to, you will receive 1 of 2 doses of the investigational medication, or a placebo (which looks just like the investigational medication but contains no active ingredients).

If you participate, neither you nor the study doctor will know whether you are receiving the placebo or the investigational medication. For every 4 participants, 1 will receive the placebo and 3 will receive the investigational medicaition. The investigational medication and placebo together are referred to as the “study medication”.

The study medication will be taken as 1 capsule by mouth each day for up to 8 weeks. You will take the capsule with a glass of water during a meal.